IceCure’s ProSense Cryoablation Posts 99.02% 17-Year Control, Eyes H2 2026 Japan Approval
ICCM•An article in the International Journal of Surgery reports IceCure’s ProSense cryoablation achieved a 99.02% 17-year recurrence-free rate versus 98.6% for radiofrequency ablation in early-stage breast cancer. IceCure will present findings at the Japanese Breast Cancer Society meeting and Terumo will seek PMDA approval for ProSense in H2 2026.
1. Journal Publication
IceCure’s ProSense cryoablation benefits were published in the International Journal of Surgery, ranked third globally among surgical journals. The peer-reviewed article authored by leading Japanese specialists evaluates thermal ablation versus radiofrequency ablation as a minimally invasive alternative to breast-conserving surgery.
2. Clinical Outcomes
The study cites a 99.02% recurrence-free rate from over 600 patients treated with ProSense cryoablation over up to 17 years, versus a 98.6% five-year ipsilateral breast tumor-free rate in radiofrequency ablation (RAFAELO study). Key advantages include local anesthesia, visible ice-ball margins and reduced scarring.
3. Japan Meeting and Regulatory Path
IceCure will present these findings at the 34th Annual Meeting of the Japanese Breast Cancer Society in Kyoto on June 25-27, 2026. Terumo Corporation plans to submit ProSense for PMDA approval in H2 2026, leveraging international and Japanese clinical data to expand market access.
